Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

paion deutschland gmbh - remimazolam besilate - sedazzjoni konxja - psikolettiċi - remimazolam is indicated in adults for procedural sedation. remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosoppressanti - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapenem sodium - infezzjonijiet batteriċi - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4. 4 u 5. 1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4. 4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - doripenem - pneumonia, ventilator-associated; pneumonia, bacterial; urinary tract infections; bacterial infections; cross infection - antibatteriċi għal użu sistemiku, - doribax huwa indikat għall-kura ta 'l-infezzjonijiet li ġejjin fl-adulti:pnewmonja nożokomjali (inkluż pulmonite assoċjata ma'); infezzjonijiet intra-addominali;ikkumplikati tal-passaġġ urinarju. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

instituto grifols s.a. - l-immunoglobulina normali umana - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - sera immuni u immunoglobulini, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - epatite b, antiġen tal-wiċċ rikombinanti - hepatitis b; immunization - vaċċini - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma sseħħx fin-nuqqas ta ' infezzjoni tal-epatite b.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertapenem sodium - community-acquired infections; streptococcal infections; staphylococcal infections; gram-negative bacterial infections; surgical wound infection; pneumonia, bacterial - antibatteriċi għal użu sistemiku, - treatmenttreatment ta ' l-infezzjonijiet meta jkunu kkawżati minn batterji li huma magħrufa jew x'aktarx li jkunu suxxettibbli għal ertapenem u meta t-terapija parenterali hija meħtieġa:infezzjonijiet intra-addominali;pnewmonja akkwiżita fil-komunità;l-infezzjonijiet ġinekoloġiċi akuti;infezzjonijiet dijabetiċi fis-saqajn tal-ġilda u tat-tessut artab. preventioninvanz huwa indikat fl-adulti għall-profilassi ta'infezzjoni fis-sit kirurġiku wara operazzjoni mhux obbligatorja tal-kolorektum-kirurġija. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.